Table 1.
Summary of the main characteristics of virological tools used for simplified diagnosis strategies
HCV RNA using NAAT | HCV RNA using DBS | HCV RNA POCT | HCV c Ag | |
---|---|---|---|---|
Analytical performances | Excellent sensitivity <25 IU/ml | Should only be used as a qualitative result |
Expected to be excellent. Need to be determined in real life settings |
Equivalent to 500 to 3000 IU/ml, according to the HCV genotype |
Target population |
Centralized settings” High income countries |
Lack of access to sites or nearby laboratory facilities for NAAT Persons with poor venous access (e.g. in drug treatment programs, prisons). |
Lack of access to sites or nearby laboratory facilities for NAAT if using fingerstick: Persons with poor venous access (e.g. in drug treatment programs, prisons). |
Centralized settings Low and middle income countries |
Specimen type | Serum/plasma requires venipuncture to obtain specimen | Fingerstick capillary whole blood samples | Whole blood samples but more data are warranted |
Serum requires venipuncture to obtain specimen. Whole blood from DBS but sensitivity is poor |
Time of result | Time to result: several hours/days and generally batched as one run | Several days | <120 min | <60 min |
Laboratory infrastructure |
Requires trained laboratory technician Requires laboratory facilities and equipment |
Can be performed in decentralized settings | Can be performed in decentralized settings | Requires laboratory facilities and equipment |
Standardization | Need for development of standardized protocols by manufacturers |
NAAT, nucleic acid amplification technologies; POC, point‐of‐care; HCV cAg , HCV core antigen.